Due to disease, often cancer, it may be necessary to remove the larynx by surgery (laryngectomy). By removal of the larynx several important functions are lost. The epiglottis and the closing function thereof is lost, and therefore an opening into trachea, a tracheostoma, has to be provided in the neck of the patient in order to create a direct connection with trachea. The tracheostoma is sometimes lowered (depressed) in relation to the surface of the patient's neck around the stoma and may have an irregular form because it is often necessary to remove tissue around the stoma.
The vocal cords and thus the ability to speak are also lost. In order to re-create a kind of speech a fistula is formed by surgery between oesophagus and trachea, and a voice prosthesis which is a one-way valve (U.S. Pat. No. 5,578,083) is placed therein. By means of a finger or a tracheostoma valve the tracheostoma can be closed off in order to prevent air from going out through the tracheostoma, air being pressed from the lungs to oesophagus through the voice prosthesis whereby the mucosa of oesophagus is starting to vibrate and it is possible to speak (U.S. Pat. No. 4,325,366).
It is also known to connect some kind of heat and moisture exchanger to the tracheostoma. Therefore, the expression “tracheostoma valve” as used in the present description is meant to include any other appliance connected to the tracheostoma.
Irrespectively of the kind of appliance that is connected to the tracheostoma, the most common way to accomplish said connection is by means of an annular flange flange attached to the patient's neck by means of an adhesive. However, there is on the market also a disposable plaster for attaching tracheostoma valves to the neck, and this plaster is formed of a single-coated tape fixed to a flange. The flange forms a socket and a plane flange fixed to the tape. The plaster has a generally plane surface to be attached to the skin surrounding the tracheostoma. This type of plaster causes problems regarding tension and incomplete contact with the skin close to the tracheostoma due to the fact that the stoma normally is lowered or depressed.
Further prior art means for attachment to a patient's neck in connection with a tracheostoma includes an annular flange and a socket integral with the flange and projecting from one side thereof at an angle to the axis of the socket. The tracheostoma valve is exchangeably received in the socket. The flange is made of plasticized PVC. A double-coated tape is attached to the flange on the other side thereof as means for attaching the flange against the skin surrounding the tracheostoma. The tape must not extend beyond the edge of the flange, as any exposed adhesive of the tape will attract dirt and dust discolouring the tape. The flange is to be reused. Thus, when the tape is to be replaced the patient first has to remove the double-coated tape from the flange, clean the flange with a solvent, let the flange dry, and then apply a new double-coated tape to the flange. This procedure is repeated at least once a day.
Though the products of the above type work well in many respects, there are still some problems. The known products are normally of a type to be re-used, which means that cumbersome cleaning by means of unhealthy solvents has to be effected. Often the patient is elderly and will find problems in performing these steps. In order that the tape shall adhere to the flange this is made of plasticized polyvinyl chloride (PVC). This plastic is known to cause health problems and accordingly should be avoided. The tape is fixed to the whole area of the flange, which means that it relatively easy may come loose from the skin due to the fact that a large force is concentrated to the tape edge adjacent the tracheostoma. When the tracheostoma valve is used during speaking and coughing or is to be removed, the socket is exposed to large axial forces, putting the tape edge adjacent the socket under tension. As the flange is relatively small and the adhesive tape does not extend beyond it or at least not far beyond it, it is difficult to have sufficient adherence on patients having a large and irregular tracheostoma. The flange is inclined but since the tracheostoma often is lowered or depressed and the skin around the tracheostoma often is relatively plane the inclined flange will cause surrounding skin to adapt an unnatural form and in this way creates tensions in the tissues and thus becomes uncomfortable to the patient. Furthermore, there is an increased risk that the plaster will more easily loosen from the patient's neck.